Clinical trialPhase 1 / Phase 2Completed
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133
Clinical Study of Chimeric CD(Cluster of Differentiation)133 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- June 2015
- Ended
- June 2019
- Enrollment
- 20 participants
- Sites
- 1
- Primary outcomes
- Occurrence of study related adverse events
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 17 December 2019
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
Detailed description public domain (ClinicalTrials.gov)
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD133 (cluster of differentiation antigen 133 ) vector (referred to as CART-133 cells). II. Determine duration of in vivo survival of CART-133 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-133 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time. SECONDARY OBJECTIVES: I. For patients with detectable disease, measure anti-tumor response due to CART-133 cell infusions. II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-133 TCR zeta:CD137 and TCR zeta cells over time. III. Estimate relative trafficking of CART-133 cells to tumor in bone marrow and lymph nodes. IV. For patients with stored or accessible tumor cells determine tumor cell killing by CART-133 cells in vitro. V. Determine if cellular or humoral host immunity develops against the murine anti-CD133, and assess correlation with loss of detectable CART-133 (loss of engraftment). VI. Determine the relative subsets of CART-133 T cells (Tcm, Tem, and Treg).
Papers 2
- Builds on itEfficacy and biomarker analysis of CD133-directed CAR T cells in advanced hepatocellular carcinoma: a single-arm, open-… DOI 10.1080/2162402x.2020.1846926↗
- Builds on itCocktail treatment with EGFR-specific and CD133-specific chimeric antigen receptor-modified T cells in a patient with a… DOI 10.1186/s13045-016-0378-7↗